P Rom

Uses

P Rom is used for:

• Severe infections, such as septicemia, bacteremia and infections in immunosuppressed neutropenic patients with hematological malignancies
• Lower respiratory infections including pneumonia
• Severe urinary tract infections including pyelonephritis
• Skin and soft tissue infections
• Bone and joint infections
• Infections in immunocompromised patients
• Other infections

P Rom is also used to associated treatment for these conditions: Gram-negative infections Bacterial Infections, Infections, Gram-Positive Bacterial

Dosage

P Rom dosage

Adult:1-2 gm every 12 hour via IV injection over 3-5 minutes or infuse over 20-30 minutes.

Elderly:There are no special precautions for its use in the elderly provided dosage is adjusted accordingly to renal function.

P Rom is administered only through the parenteral route. The dosage is dependent upon the severity and site of infection, the susceptibility of the infecting microorganisms and age, weight and renal function of the patient. The drug is administered through intravenous injection or infusion. The following dosages are recommended for moderate to severe infections in adult patients with normal renal function:

• Complicated upper & lower urinary tract infections: 1 gm 12 hourly.Total daily dose not more then 2 gm
• Skin & soft tissue infections:1 gm 12 hourly.Total daily dose not more then 2 gm
• Lower respiratory tract infections:1 to 2 gm 12 hourly.Total daily dose not more then 2 to 4 gm
• Bacteraemia or septicaemia and severe infections: 2gm 12 hourly.Total daily dose not more then 4 gm
• Infections in neutropenic patients:2gm 12 hourly.Total daily dose not more then 4 gm

Dose reduction is necessary in patients with markedly reduced renal function. After an initial dose of 0.5 -2 gm to establish a high serum concentration, the dose should be reduced by 50% for clearances of 49-21 ml/min or 75% for clearances of 20 ml/min. In end-stage renal disease, a supplementary dose equal to 50% of the recommended daily dose should be administered after each hemodialysis treatment.

The duration of treatment depends on the patient’s clinical and bacteriological response.

It is highly recommended to use the reconstituted solution immediately. During reconstitution the following procedure to be recommended and after reconstitution use within specified time line maintaining storage condition.

Step 1: Add recommended volume of solvent slowly. Remove the syringe needle.

Step 2: Gently shake the vial to dissolve the powder. Carbon dioxide is released & a clear solution will be obtained.

Step 3: Now insert the needle in the free space of the reconstituted vial & withdraw the pressurized air from the free space.

Step 4: Finally withdraw the solution from the vial by syringe.

Side Effects

P Rom is generally well tolerated. There are no predictable life threatening effects of P Rom. Adverse gastrointestinal reactions include diarrhea, nausea, vomiting, pseudomembraneous colitis, abdominal pain and have been noted 3.86% of the patients. Superficial phlebitis, thrombophlebitis and infection site reaction have been reported in 2.31% of patients receiving intravenous P Rom.

Precaution

Allergy to penicillin or to cephalosporins; renal impairment, monitor renal and haematological status; pregnancy and lactation.

Interaction

Drug interactions have not been observed with P Rom.

Pregnancy & Breastfeeding use

The safety of P Rom has not been established in pregnancy and as with all agents it should be administered with caution, especially during the early months of pregnancy. As P Rom is excreted in human breast milk, either P Rom treatment should be discontinued or breast feeding ceased.

Contraindication

P Rom is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Acute Overdose

No cases of over dosage are known. However, general supportive care with monitoring of renal, hematological and hepatic function and coagulation status is recommended.

Storage Condition

P Rom vial should be stored below 25° C, protected from light and moisture. Reconstituted solution can be stored for up to 6 hours at room temperature and 24 hours in refrigerator (at 2-8° C) when prepared in water for injection.

Innovators Monograph

You find simplified version here P Rom